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Polysorbate 20, Multi-Compendial, J.T.Baker®
Polysorbate 20, Multi-Compendial, J.T.Baker®
Catalog #: CAJT4115-04
CAS Number:  9005-64-5
Polysorbate 20, Multi-Compendial, J.T.Baker®
Polysorbate 20, Multi-Compendial, J.T.Baker®
Catalog #: CAJT4115-04
CAS Number:  9005-64-5
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Specifications

  • Packaging:
    Glass bottle
  • Size:
    200 ml
  • Cat. no.:
    CAJT4115-04

Specifications

Specification Test Results

  • ChP - Peroxide Value:
    ≤ 10
  • ChP - Identification 1:
    Passes Test
  • ChP - Identification 2:
    Passes Test
  • ChP - Identification 3:
    Passes Test
  • ChP - Acidity or Alkalinity (pH):
    4.0 - 7.5
  • ChP - Color:
    Passes Test
  • ChP - Ethylene glycol:
    ≤ 0.01 %
  • ChP - Diethylene glycol:
    ≤ 0.01 %
  • ChP - Ethylene Oxide:
    ≤ 0.0001 %
  • ChP - Water:
    ≤ 3.0 %
  • ChP - Dioxane:
    ≤ 0.001 %
  • ChP - Heavy Metals:
    ≤ 10 ppm
  • ChP - Arsenic:
    ≤ 0.0002 %
  • ChP - Fatty Acid Composition: Lauric acid:
    40.0 - 60.0 %
  • ChP - Fatty Acid Composition: Myristic acid:
    14.0 - 25.0 %
  • ChP - Fatty Acid Composition: Palmitic acid:
    7.0 - 15.0 %
  • ChP - Fatty Acid Composition: Caproic acid:
    ≤ 1.0 %
  • ChP - Fatty Acid Composition: Caprylic acid:
    ≤ 10.0 %
  • ChP - Fatty Acid Composition: Capric acid:
    ≤ 10.0 %
  • ChP - Fatty Acid Composition: Stearic acid:
    ≤ 7.0 %
  • ChP - Fatty Acid Composition: Oleic acid:
    ≤ 11.0 %
  • ChP - Fatty Acid Composition: Linoleic acid:
    ≤ 3.0 %
  • Endotoxin Concentration (EU/mL):
    ≤ 10
  • Peroxide Value, meqO2/kg:
    ≤ 2.0
  • Appearance:
    Passes Test
  • pH of 5% solution at 25°C:
    5.0 - 7.0
  • Arsenic:
    ≤ 1 ppm
  • Ethylene glycol:
    ≤ 0.10 %
  • Diethylene glycol :
    ≤ 0.10 %
  • Vegetable Based:
  • This product utilizes ingredients of non-animal origin and non-peanut origin.:
  • Only Class 2 (1,4 Dioxane, Ethylene Glycol) and Class 3 (2-propanol) solvents are likely to be present. Class 2 solvents are below the Option 1 limits and any Class 3 solvent is <0,5%.:
  • Suitable for use in injectable dosage forms.:
  • Elemental Impurities (USP 232, EP 5.20) - Information on elemental impurities for this product is available on the associated Product Regulatory Data Sheet and elemental impurity profile report.:
  • GMP Manufactured Product:
  • Meets B.P. Chemical Specifications:
  • Meets ChP Chemical Specifications:
  • Meets E.P. Chemical Specifications:
  • Meets JPE Specifications:
  • Meets N.F. Requirements:
  • CAUTION: For Manufacturing, processing or repackaging:
  • Bulk Pharmaceutical Chemical:
  • NF - Acid Value:
    ≤ 2.0
  • NF - Residue on Ignition:
    ≤ 0.25 %
  • NF - Dioxane:
    ≤ 10 ppm
  • NF - Ethylene Oxide:
    ≤ 1 ppm
  • NF - Hydroxyl Value, mg KOH/g:
    96 - 108
  • NF - Identification A:
    Passes Test
  • NF - Identification B:
    Passes Test
  • NF - Saponification Value, mg KOH/g:
    40 - 50
  • NF - Caproic Acid (Composition of Fatty Acids):
    ≤ 1.0 %
  • NF - Caprylic Acid (Composition of Fatty Acids):
    ≤ 10.0 %
  • NF - Capric Acid (Composition of Fatty Acids):
    ≤ 10.0 %
  • NF - Lauric Acid (Composition of Fatty Acids):
    40.0 - 60.0 %
  • NF - Myristic Acid (Composition of Fatty Acids):
    14.0 - 25.0 %
  • NF - Palmitic Acid (Composition of Fatty Acids):
    7.0 - 15.0 %
  • NF - Stearic Acid (Composition of Fatty Acids):
    ≤ 11.0 %
  • NF - Oleic Acid (Composition of Fatty Acids):
    ≤ 11.0 %
  • NF - Linoleic Acid (Composition of Fatty Acids):
    ≤ 3.0 %
  • NF - Peroxide Value:
    ≤ 5.0
  • NF - Water (H₂O):
    ≤ 3.0 %
  • EP/BP - Acid Value:
    ≤ 2.0
  • EP/BP - Total Ash:
    ≤ 0.25 %
  • EP/BP - Composition of Fatty Acids - Caproic Acid:
    ≤ 1.0 %
  • EP/BP - Composition of Fatty Acids - Caprylic Acid:
    ≤ 10.0 %
  • EP/BP - Composition of Fatty Acids - Capric Acid:
    ≤ 10.0 %
  • EP/BP - Composition of Fatty Acids - Lauric Acid:
    40.0 - 60.0 %
  • EP/BP - Composition of Fatty Acids - Myristic Acid:
    14.0 - 25.0 %
  • EP/BP -Composition of Fatty Acids - Palmitic Acid:
    7.0 - 15.0 %
  • EP/BP - Composition of Fatty Acids - Stearic Acid:
    ≤ 7.0 %
  • EP/BP - Composition of Fatty Acids - Oleic Acid:
    ≤ 11.0 %
  • EP/BP - Composition of Fatty Acids - Linoleic Acid:
    ≤ 3.0 %
  • EP - Identification A:
    Passes Test
  • EP - Identification D:
    Passes Test
  • EP/BP - Hydroxyl Value:
    96 - 108
  • EP - Peroxide Value:
    ≤ 10.0
  • EP - Saponification Value:
    40 - 50
  • EP - Water (H₂O):
    ≤ 3.0 %
  • EP - Ethylene Oxide:
    ≤ 1 ppm
  • EP - Dioxan:
    ≤ 10 ppm
  • Microbiological - Total Aerobic Microbial Count (cfu/g):
    ≤ 100
  • Microbiological - Escherichia Coli:
    Passes Test
  • Microbiological - Pseudomonas aeruginosa:
    Passes Test
  • Microbiological - Salmonella:
    Passes Test
  • Microbiological - Staphylococcus aureus:
    Passes Test
  • Microbiological - Total Yeast and Mold Count (cfu/g):
    ≤ 50
  • JPE - Identification 1:
    Passes Test
  • JPE - Identification 2:
    Passes Test
  • JPE - Identification 3:
    Passes Test
  • JPE - Moisture Content:
    ≤ 3.0 %
  • JPE - Acid Value:
    ≤ 4.0
  • JPE - Saponification Value (mg KOH/g):
    43 - 55
  • JPE - pH:
    4.0 - 7.0
  • JPE - Residue on Ignition:
    ≤ 0.25 %
  • JPE - Specific Gravity at 20°C:
    1.090 - 1.130
  • JPE - Viscosity (mm²/S):
    350 - 550
  • JPE - Heavy Metals (as Pb):
    ≤ 20 ppm
  • JPE - Arsenic (As):
    ≤ 2 ppm
  • ChP - Relative Density @ 20 C:
    1.09 - 1.12
  • ChP - Viscosity, mm2/s @ 25 C:
    250 - 400
  • ChP - Acid Value,meq/g:
    ≤ 2.0
  • ChP - Saponification Value:
    40 - 50
  • ChP - Hydroxyl Value:
    96 - 108
  • J.T.Baker®, Polysorbate 20, Multi-Compendial:

Specification Test Results

About this item

Synonyms: Polyoxyethylene-20-Sorbitan Monolaurate,Sorbitan monolaurate
 :Storage temperature: Ambient
Density:1.11 g/cm³
 :Length:
 :Width:
 :Height:
 :Ø
 :Thickness:
 :Management of Change (MOC) category = R
 :Boiling Pt:
 :Boiling Pt:
 :Melting Pt:
 :Flash Pt:
 :Flash Pt:
Formula:C₅₈H₁₁₄O₂₆
Storage Temperature:Ambient
MDL Number:MFCD00165986
CAS Number:9005-64-5
EINECS:500-018-3
 :M.O.C. Category R
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